Multiple Sclerosis Clinical Trial
Official title:
A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients
Primary Objective:
To describe efficacy, tolerability and convenience of teriflunomide treatment through the
evaluation of Patient Reported Outcomes (PROs).
Secondary Objectives:
To describe disease progression using Patient Reported Outcomes (PROs). To describe clinical
outcomes (ie, treated relapses) in teriflunomide treated patients.
To describe the change in cognition in teriflunomide treated patients. To describe safety of
teriflunomide in patients treated (based on adverse events reporting).
To describe adherence and persistence to teriflunomide treatment. To describe quality of
life, activity and leisure over the period of teriflunomide treatment.
To compare Patient Determined Disease Steps (PDDS) and Expanded Disability Status Scale
(EDSS) in assessing Multiple Sclerosis (MS) disease progression.
The total duration of the study per patient is up to 50 or 54 weeks (if accelerated
elimination procedure performed):
Screening: up to 2 weeks Teriflunomide treatment: 48 weeks Accelerated elimination
procedure: 4 weeks when performed)
An accelerated elimination procedure at any time after discontinuation of teriflunomide
treatment is possible and it is particularly recommended for women of child-bearing
potential.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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